Evaluating a new treatment for chronic hepatitis delta infection
A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)
This study is testing a new combination treatment for chronic hepatitis delta infection to see if it works better than waiting for treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Vir Biotechnology, Inc. Industry-sponsored |
| Locations | 6 sites (Chandler, Arizona and 5 other locations) |
| Trial ID | NCT06903338 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, randomized Phase 3 clinical study aims to assess the efficacy and safety of the combination of tobevibart and elebsiran for treating chronic hepatitis delta virus (HDV) infection. Participants will be compared to a group receiving delayed treatment to determine the effectiveness of the new therapy. The study includes adults aged 18 to 70 with chronic HDV infection and specific liver function criteria. The goal is to provide a potential new treatment option for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with chronic HDV infection who are on NRTI therapy and meet specific liver function criteria.
Not a fit: Patients with significant liver disease from non-HBV or non-HDV causes or those with a history of severe allergic reactions to the study drugs may not benefit.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with chronic hepatitis delta infection.
How similar studies have performed: Other studies have explored treatments for hepatitis delta, but the combination of tobevibart and elebsiran represents a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female ages 18 to 70 years at screening 2. Chronic HDV infection for \>/= 6 months 3. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy 4. Serum ALT \> ULN and \< 5x ULN 5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening Exclusion Criteria: 1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 2. History of significant liver disease from non-HBV or non-HDV etiology 3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 4. History of anaphylaxis 5. History of immune complex disease 6. History of autoimmune disorder 7. History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication
Where this trial is running
Chandler, Arizona and 5 other locations
- Investigative Site — Chandler, Arizona, United States (Recruiting)
- Investigative Site — DeLand, Florida, United States (Recruiting)
- Investigative Site — Hillsborough, New Jersey, United States (Recruiting)
- Investigative Site — Seattle, Washington, United States (Recruiting)
- Investigative Site — Montréal, Quebec, Canada (Recruiting)
- Investigative Site — Chisinau, Moldova, Republic of (Recruiting)
Study contacts
- Study coordinator: Study Inquiry
- Email: clinicaltrials@vir.bio
- Phone: 415-654-5281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.